New York, New York 10010


Purpose:

This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.


Study summary:

Veterans with diabetes who have had a previous ulcer are at highest risk for new ulcers and amputation, particularly if they have neuropathy or vascular disease and have poor foot self-care or nonadherence to diet, medication, and exercise recommendations. It is difficult to activate at-risk patients to improve self-care and detect foot abnormalities or inflammation at an early stage. Proposed is a randomized controlled trial testing the effectiveness of a comprehensive tailored intervention (TI) aimed to improve self-care and self-monitoring (including dermal thermometry) through behavioral counseling. The primary specific aim is to evaluate if TI reduces the proportion of recurrent ulcers at 18 months compared to the current practice (CP) group. The secondary specific aims are to evaluate the impact of TI on time to ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills compared to the CP group. The investigators will recruit adults with diabetes who have had a previously healed ulcer. The intervention will be standardized and fidelity of the intervention will be maintained. Using a blinded randomized controlled trial (RCT), the investigators will test the effect of TI in relation to CP. Key outcomes are ulceration, quality of life (QOL), plantar pressure, physical activity and foot care skills. Outcomes will be measured at baseline, 6, 12 and 18 months. All analyses will be intent-to-treat. This study will evaluate a comprehensive tailored intervention targeting multiple behaviors related to self-care and amputation risk. This study applies advanced behavioral theories to intervene to improve care for veterans at risk for amputation combined with dermal thermometry. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed for these vulnerable Veterans with a previous ulcer, it will be an important scientific contribution that could lower the risk of recurrent ulcers and amputation in Veterans with diabetes.


Criteria:

Inclusion Criteria: - Adults (21 years) with Type 2 diabetes - History of healed diabetic foot ulcer (>3 months) - Diabetes drug therapy for > 6 months - An available phone and receiving continuity of care at the VA (at least 2 primary care visits in the previous 1.5 years at the recruitment site) Exclusion Criteria: - Patients with an active foot ulcer - Acute cardiovascular disease (CVD) events < 3 months ago - Poor estimated short-term survival (< 1 year) - Recent major surgery (< 3 months) - Prior foot amputation - Inability to exercise - Temporary residence in the area - Inability to provide consent will be excluded


NCT ID:

NCT02356848


Primary Contact:

Principal Investigator
Sundar Natarajan, MD MSc
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Sundar Natarajan, MD MSc
Phone: (212) 686-5000
Email: sundar.natarajan@va.gov


Backup Contact:

N/A


Location Contact:

New York, New York 10010
United States

John G Hay, MD
Phone: 212-686-7500
Email: john.hay@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.